Placebo Evaluate
Conditions
Keywords
Traditional Chinese medicine, blinding, physical consistency, evaluation method
Brief summary
TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine Zhongfengxingnao formula (ZFXN) in reducing haematoma and bleeding after acute intracerebral hemorrhage (ICH) from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study is designed to evaluate the blinding and physical consistency between the investigational drug and placebo in RCT, taking the trial named Chinese herbal medicine in patients with acute intracerebral hemorrhage (CHAIN) as an example. Therefore the blinding of placebo as well as and physical consistency with investigated TCM in CHAIN trial will be determined. In addition, an assessment method for blinding and physical consistency could be developed for subsequent placebo evaluations.
Detailed description
A total of 48 subjects will be divided into two parts for manual scoring, which includes not only the proportion of the discrimination to ZFXN, which is the primary outcome in this study, but also the physical (odor, taste) consistency of the two drugs. The primary outcome was the percentage of ZFXN response. The secondary outcomes included artificial sensory score and intelligent sensory attributes of testing drug.
Interventions
Oral liquid 10ml
Sponsors
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 1\. Age ≥18 years old; * 2\. No visual, olfactory, taste, cognitive impairment; * 3\. Provide written informed consent by patient (or approved surrogate);
Exclusion criteria
* 1\. Evaluation personnel involved in the clinical trial about ZFXN; * 2\. Subjects with severe history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders or metabolic disorders; * 3\. Subject with history of food, drug allergies, or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) or is known to be allergic toZFXN; * 4\. Known definite contraindication to the Chinese herbal medicine; * 5\. Women who are known to be pregnant or lactating; * 6\. Subjects not fit to participate in this study judged by responsible treating clinician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of ZFXN response | Within 10 minutes after the first test. | The incidence of judging testing drug as ZFXN |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The artificial sensory score of testing drug | Within 10 minutes after the second test. | Compare the consistency or difference of artificial sensory (odor, taste) score between two drugs. The value range from 0 to 10: higher scores mean a better consistency. |
| The intelligent sensory attributes of testing drug | Immediately after testing by electronic nose an electronic tongue. | Compare the consistency or difference of artificial sensory (odor, taste) score between two drugs. |
Countries
China
Outcome results
None listed